Ferozsons Laboratories has entered into a voluntary licensing agreement with Gilead Sciences Ireland UC to manufacture and distribute generic lenacapavir HIV prevention drug in resource-limited countries, the company announced in a PSX filing on October 3.
This collaboration marks a significant step in expanding access to essential HIV treatment in low- and middle-income regions.
Expanding HIV Treatment in 120 countries
Gilead Sciences has granted royalty-free licenses to six generic drug manufacturers to make and sell cheaper copycat versions of its HIV prevention medicine in 120 low and lower-middle-income countries, including Pakistan, India, Ukraine and Thailand. Gilead signed licensing agreements with Pakistan-based Ferozsons Laboratories, India’s Dr. Reddy’s Laboratories, Emcure Pharmaceuticals and Hetero Labs, as well as US-based Viatris’ unit Mylan, and Egypt’s Eva Pharma.
Under the agreement, Ferozsons will produce and distribute generic lenacapavir across 120 low- and middle-income countries, subject to regulatory approvals. The company will also receive a technology transfer of Gilead’s manufacturing process for lenacapavir, enabling it to scale up production. The expanded production capacity will be critical in meeting the high demand for HIV treatments in resource-constrained settings.
Lenacapavir, a unique antiviral agent, is used in heavily treatment-experienced (HTE) patients with HIV and is currently being studied for HIV prevention. Its mechanism of action is different from other approved antiviral drugs, as it inhibits the virus at multiple stages of its lifecycle. This feature makes it a valuable option for patients who have developed resistance to other treatments. The drug has also shown no cross-resistance in vitro with other existing HIV drug classes, making it an innovative treatment solution.
Manufacturing and Distribution Plans
Ferozsons will produce the injectable form of lenacapavir, which is administered as a vial kit with a concentration of 309 mg/mL, at its joint venture subsidiary, BF Biosciences Limited. Meanwhile, the oral version, containing 300 mg of lenacapavir per tablet, will be manufactured at its oral solid dosage facility. Both forms will be subject to rigorous quality control to meet international standards, ensuring that patients receive high-quality treatment.
The injectable version is particularly significant because of its long-acting properties, making it easier for patients to adhere to treatment schedules. Lenacapavir’s extended duration of action could alleviate the burden of daily medication for people living with HIV, especially in regions with limited healthcare infrastructure.
Global Partnership for HIV Treatment
Ferozsons is one of only six global partners selected by Gilead Sciences to manufacture generic lenacapavir. This partnership aims to make high-quality HIV treatments accessible to some of the world’s most vulnerable populations. By leveraging Gilead’s expertise and Ferozsons’ manufacturing capabilities, the two companies hope to provide affordable treatment options for millions of people affected by HIV.
Gilead Sciences, a leading US biopharmaceutical company, is known for developing innovative medicines to address unmet medical needs. Ferozsons, established in Pakistan in 1956, has built a strong reputation for its broad range of pharmaceutical products and international collaborations, positioning itself as a key player in the global pharmaceutical industry.